Location: St. Paul, MN
Duration: 12 months
- Prepares robust regulatory applications or technical file documentation to achieve departmental and organizational objectives and support EU MDR transition activities.
- Creates, reviews and approves engineering change orders.
- May act or assist as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
- May act or assist as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
- Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Interfaces directly with FDA and other regulatory agencies.
- Supports the product release process by reviewing and approving requests for product release.
- Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
- Reviews protocols and reports to support regulatory submissions.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, as assigned.
- BA or BS degree (degree in a technical discipline highly preferred).
- A minimum of 5 years of technical experience, including at least 2 years of regulatory experience in a medical device industry.
- Experience with 510(k) applications, PMA supplements and US device regulations and experience with EU and other international medical device regulations and submissions.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including internationally.
- Ability to maintain regular and predictable attendance.
- Ability to identify and solve problems and work independently with little oversight.